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Ronozyme® HiPhos - 4a18i

6-phytase (EC 3.1.3.26)

Details

Publication date
26 January 2018 (Last updated on: 1 March 2018)

Description

In the current application authorisation is sought under article 13(3) for Ronozyme® HiPhos under the category/functional "zootechnical additives"/"digestibility enhancers". Specifically, authorisation is sought for the reduction of the minimum dose in feedingstuffs for pigs for fattening. 

According to the Applicant, the active agent of Ronozyme® HiPhos is 6-phytase. The activity of 6-phytase is expressed in phytase units (FYT). One FYT unit is defined as "the amount of enzyme that releases 1 μmol of inorganic phosphate from phytate per minute under reaction conditions with a phytate concentration of 5.0 mM at pH 5.5 and 37 °C". 

The product is marketed in solid and liquid form with a guaranteed minimum 6-phytase activity of 10000 FYT/g and 20000 FYT/g, respectively. It is intended to be included through premixtures or directly in feedingstuffs to obtain a minimum activity of 250 FYT/kg feedingstuffs

For the quantification of the phytase activity in feedingstuffs the Applicant submitted the ring-trial validated colorimetric standard method EN ISO 30024 and demonstrated the suitability of the method at 200 FYT/kg feedingstuffs. In addition, the Applicant applied this method with minor experimental modifications to analyse the feed additive (Ronozyme® HiPhos) and premixtures and obtained similar method performance characteristics. 

Based on the performance characteristics available the EURL recommends for official control the colorimetric methods mentioned above for the quantification of the phytase activity in the feed additive, premixtures and feedingstuffs

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005) is not considered necessary.

Recommended Method

as of:

-Commission Implementing Regulation (EU) 2023/1342

For the quantification of phytase activity in the feed additive: 

colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4

For the quantification of phytase activity in compound feeds: 

colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024

For the quantification of phytase activity in premixtures: 

colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.3

Files

  • 1 MARCH 2018
finrep-fad-2017-0021-ronozyme_hiphos.pdf